Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

NCT03486496 | Unknown Phase 2 DMC

• 1 other identifier: CSWOF201801
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators hypothesize that progression-free survival could be improved by combination of gefitinib and berberine.

Conditions

Lung Adenocarcinoma; EGFR Mutation

Keywords

Lung Adenocarcinoma; EGFR mutation; Gefitinib; Berberine

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)

  Within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient

Secondary Outcomes (2)

• Objective response

  through study completion,an average of three years

• safety

  Within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient

Study Arms (1)

Gefitinib and Berberine

EXPERIMENTAL

Experimental: Gefitinib and Berberine Patients will be treated with Gefitinib and Berberine. Gefitinib: 250 mg p.o., daily. Berberine: 50 mg p.o., tid.

Drug: gefitinib; Drug: Berberine

Interventions

gefitinib DRUG

Patients will be treated with gefitinib, 250 mg p.o., daily

Also known as: Iressa (AstraZeneca)

Gefitinib and Berberine

Berberine DRUG

Patients will be treated with Berberine, 50 mg p.o., tid

Also known as: Berberine Sulfate

Gefitinib and Berberine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• ECOG performance status 0-2
• Adequate haematological function, coagulation, liver function and renal function
• Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
• TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
• Measurable or evaluable disease (according to RECIST 1.1 criteria).
• Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)

You may not qualify if:

• Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.
• Patients with any known significant ophthalmologic anomaly of the ocular surface
• Patients who received prior chemotherapy for metastatic disease
• Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
• Pregnancy

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian cancer hospital

Fuzhou, Fujian, China

Location

Related Publications (1)

• Fan XX, Leung EL, Xie Y, Liu ZQ, Zheng YF, Yao XJ, Lu LL, Wu JL, He JX, Yuan ZW, Fu J, Wei CL, Huang J, Xiao DK, Luo LX, Jiang ZB, Zhou YL, Kam RK, Liu L. Suppression of Lipogenesis via Reactive Oxygen Species-AMPK Signaling for Treating Malignant and Proliferative Diseases. Antioxid Redox Signal. 2018 Feb 10;28(5):339-357. doi: 10.1089/ars.2017.7090. Epub 2017 Aug 4.

  PMID: 28665143 RESULT

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Gefitinib; Berberine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds, 4 or More Rings

Study Officials

• Cheng Huang, MD.

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gen Lin, Dr.

CONTACT

00861-591-83660063; lingen197505@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: April 3, 2018
• Study Start: June 5, 2018
• Primary Completion: June 1, 2019
• Study Completion: February 1, 2020
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external indepentent Review Panel. Requesdtors will be required to sign a Data Access Agreement.

Locations

CN (1)